Yesterday the Slovene Chemicals Office announced it will issue extraordinary permits for disinfectants with approved biocidal active substances. Here the translation of that official news (link to original source).
The announcement of the COVID-19 epidemic in Slovenia has increased the need for biocidal products, product types (PT) 1 and 2 for personal and surface disinfection, especially in healthcare and other institutions. In order to ensure the efficient supply and availability of these funds, the Chemicals Bureau of the Republic of Slovenia (hereinafter: the Office) simplified the procedures for their registration. We treat these procedures as a priority, and we update the Register of Biocidal Products more frequently (weekly).
In procedures for notifying ethanol-based products, the Office prioritises notifications for occupational-institutional use (such as in health centers, police and civil protection units and in companies).
Notifications
Disinfectants that qualify for notification and contain the active substances at concentrations included in the lists of guidelines of the European Center for Disease Prevention and Control are not required to have efficacy tests.
Modification of the active substance in a biocidal product shall be considered as a new biocidal product.
Extraordinary authorizations for disinfectants with approved biocidal active substances
In the case of biocidal active substances already evaluated and approved (such as propan-1-ol, propan-2-ol, hydrogen peroxide,…), the Office shall issue an extraordinary permit under Article 55 (1) of Regulation (EU) No 1095/2010. 528/2012 on the making available on the market and use of biocidal products ('BPR'). The issuance of extraordinary licenses is decided by the Office on the basis of a need actually demonstrated and cannot be used for products that cannot be considered as essential in the current situation.
An application for approval under Article 55 (1) must contain the following information:
- The exact name and address of the company to which the emergency permit will read.
- Trade name of the product
- 100% product composition and function / purpose of each substance in the product
- Product Safety Data Sheet
- A sample label, which must contain at least:
- Purpose of use
- Users
- Dose and route of administration
- Place of production of the product
- Estimated quantity of product produced and production commenced
- Planned packaging (size, material)
- Expected product availability (recipients)
The Office may grant a license for a maximum of 180 days for limited use under the supervision of the competent authority. To the extent that the active substances do not meet the conditions laid down in Article 95 of Regulation 528/2012 / EU, the Office shall take into account their technical equivalence in terms of their purity. ECHA recommendations.
Disinfectants approved for accessibility and use under this procedure, which will not contain the active substances of approved suppliers under Article 95, will no longer be allowed to be placed on the market and used after the expiry of the licenses, so applicants are advised to regulate the status of the emergency license during the validity period. of the active substance in one of the following ways:
- by liaising with the supplier of the active substance listed in Article 95 of the BPR,
- by obtaining a LoA, or
- with a request to be included in the supplier list in accordance with Article 95 of the BPR.
More information: https://echa.europa.eu/en/information-on-chemicals/active-substance-suppliers
Efficiency
Products placed on the market and used for the disinfection of persons and surfaces MUST be effective in the prescribed method of use. The criteria and principles for determining and indicating efficacy are set out in the Guidelines of the European Chemical Agency (ECHA), sections 5.4.1 and 5.4.2, accessible on this link.
SARS-CoV-2 virus is one of the enveloped viruses, so products with a proven antiviral or envelope virus effect can be marketed to work against it. The effect must be tested and demonstrated in accordance with EN 14476, following the above guidelines.
However, products that have an anti-virus effect, which has not been validated as stated above, are not allowed to be offered, advertised or marketed for use against viruses, as they are misleading and endangering users. Applicants who have submitted the results of studies performed using other procedures as evidence of virus efficacy are urged to verify their compliance with the above guidelines and standards and, if necessary, to harmonize the presentation (advertising, label and instructions).
The European Commission, in cooperation with the Member States and the European Chemicals Agency, has produced additional information on possible measures to increase the availability of disinfectants within the EU. The CIRCABC ('Information and guidance in relation to Covid-19 virus') website provides up-to-date information on permit conditions, emergency permits issued under Article 55 (1) of the BPR, biocidal products used in other EU Member States and on possible active substances for use in PT1 and PT2 biocidal products. Up-to-date information on accelerating the supply of disinfectants is also available on the ECHA website.
This is the end of the official notification from Chemical Office.
Please let me know if you need any help with any of this.
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